COVID-19 Situation Report |
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Editor: Alyson Browett, MPH
Contributors: Clint Haines, MS; Natasha Kaushal, MSPH; Amanda Kobokovich, MPH; Christina Potter, MSPH; Matthew Shearer, MPH; Marc Trotochaud, MSPH; and, Rachel A. Vahey, MHS.
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BOOSTER DOSES The US FDA’s Vaccines and Related Biological Products Advisory Committee during 2 days of meetings last week considered several questions related to booster doses for SARS-CoV-2 vaccines. The panel’s recommendations are not binding, although the FDA generally follows the advice of its committees.
Moderna
The vaccine advisory panel on October 14 voted unanimously to endorse a booster dose of Moderna’s SARS-CoV-2 vaccine, administered at least 6 months after the second dose. The vote supports authorizing an additional dose of the vaccine in the same groups authorized for a booster dose of the Pfizer-BioNTech SARS-CoV-2 vaccine, including individuals aged 65 and older, those ages 18 to 64 at a higher risk for severe disease, and people at risk of exposure due to their occupation. The advisory panel also discussed when booster doses should be provided to all adults but concluded it is too soon to make that decision. The Moderna booster under consideration is 50μg, half the dose of the initial 2 shots, while the authorized booster for the Pfizer-BioNTech vaccine is the same formulation as the FDA-approved 2-dose vaccine. Moderna claims a half dose is enough to activate the immune system while still stretching the world's supply of available vaccines. Data from Moderna show that the booster dose did not produce the 4-fold antibody increase set as a guideline by the FDA for authorizing boosters, but Moderna said it was because of existing high levels of antibodies in study participants. Some panel members expressed concern over some of the data provided by Moderna—including on how best to measure correlates of protection and durability provided by a half dose—but not enough to prevent endorsement of booster doses. Others noted that avoiding public confusion over which vaccines were approved for booster doses and why played a role in their decision.
J&J-Janssen
During a second day of meetings on October 15, the vaccine advisory panel voted unanimously to endorse a second dose of the J&J-Janssen SARS-CoV-2 vaccine for all recipients. This meeting saw more controversy than previous meetings on booster shots for the Pfizer-BioNTech and Moderna SARS-CoV-2 vaccines, with some panelists reportedly unhappy with multiple slides presented by J&J-Janssen that contained data not previously vetted by the FDA. Additionally, the companies presented data on boosters given at 6 months from a study with a sample size of only 17 volunteers. Panelists expressed frustration with and hesitancy to make a decision based on the limited data, but all the panelists agreed that anyone who received the J&J-Janssen vaccine should be eligible for a second dose, with some saying the vaccine should be considered as a 2-dose regimen. The concerns revolved around data showing that a single dose of J&J-Janssen offered lower protection than 2 doses of either the Pfizer-BioNTech or Moderna vaccines.
Mix & Match
Following its vote on the J&J-Janssen vaccine, the panel discussed the so-called “mix & match” strategy, which could allow heterologous booster doses for certain populations. Data from an NIH study released last week showed that the antibody levels of those who initially received the J&J-Janssen shot rose 76-fold in 15 days following a booster with Moderna and 35-fold after a booster with Pfizer-BioNTech. By comparison, a second dose of J&J-Janssen only raised antibody levels 4-fold in the same timeframe. It is worth noting that there were concerns because the NIH study results were based on a small number of volunteers and only reported short-term findings. Despite these concerns, some panelists claimed the data are enough to convince them to support a mix & match strategy, something that is fairly common in other countries.
The FDA is expected to authorize boosters for some Moderna and all J&J-Janssen vaccine recipients as early as this week and also could make a decision on the mix & match strategy. The US CDC’s Advisory Committee on Immunization Practices (ACIP) is scheduled to meet this week to make its own recommendations on booster doses, meaning millions more people in the US could be eligible for additional shots by the end of the week.
MYOCARDITIS RISK The US FDA has delayed a decision on authorizing Moderna’s SARS-CoV-2 vaccine for adolescents ages 12-17 years to allow more time to scrutinize whether the vaccine is associated with an increased risk of myocarditis, an inflammatory heart condition, particularly among young males. The move comes after several Nordic countries paused the use of the Moderna vaccine for younger males, reportedly due to an increase in reports of myocarditis. A Moderna official said the company has requested data from those countries but has not yet received the information. The FDA has said the risk of myocarditis and pericarditis—inflammation of the heart’s lining—appears to be low following vaccination with either the Moderna or Pfizer-BioNTech vaccines, and that the benefits of the vaccines outweigh the risks. But most of that data come from the vaccines’ use among adults, and the agency appears to be taking extra caution in reviewing the data on adolescents. For parents eager to vaccinate their children, the delay in authorization could increase anxiety over safety concerns or assuage any hesitancy. The timing of the FDA’s decision on the Moderna vaccine is unclear, although regulators are working expeditiously. The Pfizer-BioNTech vaccine is available for use among people aged 12 and older in the US.
US NAVY The US Navy has formed a COVID Consolidated Disposition Authority to facilitate the administrative separation of Navy service members who refuse a SARS-CoV-2 vaccine without a pending or approved exemption. The Pentagon mandated vaccination for all service members in August, after the US FDA granted full approval to the Pfizer-BioNTech SARS-CoV-2 vaccine. According to an unclassified communication, more than 98% of active duty US Navy service members have begun or completed a vaccination series, and all active duty sailors must be fully vaccinated—defined as 2 weeks after completing an authorized or approved vaccine—by November 28. Those in the Navy Reserves must be fully vaccinated by December 28. Any sailor separated only for vaccine refusal will receive “no lower than a general discharge under honorable conditions,” which could mean losing some veterans’ benefits.
EUROPE SURGE COVID-19 is once again surging in Europe, particularly in the UK and Central and Eastern Europe. The daily incidence at the continent level increased by more than 45% since the most recent low on September 16. Over the past 2 weeks, 16 European countries have reported increases in daily incidence of 25% or greater, including Czechia (+102%), Latvia (+118%), and Poland (+123%) with greater than 100%. Additionally, Ireland and the UK reported increases of 23% and 20% over that period, respectively. Europe is exhibiting similar trends in terms of daily mortality as well, with 9 countries reporting biweekly increases of 50% or more, including Poland (+103%), Romania (+109%), and Luxembourg (+300%) with increases of more than 100%. With the exception of Iceland, Ireland, and the UK, nearly all of these countries are located in the Central and Eastern regions of Europe. As Europe transitions to colder weather and winter holidays, major COVID-19 surges could pose additional risk due to increased social activities and gatherings indoors.
Russia surpassed 30,000 new cases per day for the first time on October 17 and continues to set new records for daily incidence. Russia also continues to set new records in terms of daily mortality, now up to 967 deaths per day, more than 75% higher than the previous peak in late December 2020. Reportedly, some Russian researchers have accused the Russian government of manipulating the official data, and they argue that the true figures are much worse. According to a report by The Washington Post, Russia’s official COVID-19 mortality data may “exclude many deaths” that are determined to be a result of other conditions, potentially including those known to be associated with elevated risk of severe COVID-19 disease and death.
On October 18, Latvia announced a 4-week “lockdown” period, including the closure of schools, restaurants, retail stores, and entertainment venues. Only essential services and activities will be permitted during the lockdown, and essential employees who need to work in person are required to be vaccinated. Additionally, Latvia’s COVID-19 restrictions include a curfew from 8pm-5am, with limited exceptions for traveling to or from work or receiving medical care. All schools will remain closed through October 29, and in-person classes are scheduled to resume on November 1 for grades 1-3 and November 15 for grades 4-12. The Latvian government intends to begin relaxing the lockdown measures on November 15, but initially only in “green” areas (ie, those with lower SARS-CoV-2 transmission) and only for fully vaccinated individuals.
AFRICA The WHO Regional Office for Africa (AFRO) last week estimated that only about 1 in 7 COVID-19 cases is being detected on the continent and suggested the actual cumulative COVID-19 incidence in Africa as of October 10 was about 59 million, and not the 8 million cases in official reports. In order to get a better understanding of the pandemic in Africa, the WHO announced a new initiative aimed at increasing testing access in 8 countries, with the hopes of reaching as many as 7 million people with rapid diagnostic tests in the next year. Burundi, Côte d'Ivoire, the Democratic Republic of Congo, Guinea-Bissau, Mozambique, the Republic of Congo, Senegal, and Zambia will each receive US$1.8 million to scale up testing and preventive measures using a “ring strategy,” which focuses on providing voluntary testing, face masks, and hand sanitizer to people who live within 100 meters of a confirmed COVID-19 case. The strategy successfully helped to contain and eradicate smallpox from the continent in the late 1970s, and a ring vaccination strategy has been used to contain Ebola in recent outbreaks, so it will be interesting to see how the approach works with COVID-19.
SPUTNIK V People living with HIV are at elevated risk of severe or critical COVID-19 disease and death, according to the WHO. Additionally, some researchers have long warned that vaccines that use a specific adenovirus (Ad5) vector could increase the risk of contracting HIV among certain populations. The South African Health Product Regulatory Authority this week said it would not authorize Russia’s Sputnik V vaccine, which uses Ad5, over concerns it could increase the risk of HIV infection among males. The agency said the company that makes Sputnik V did not supply data showing the vaccine is safe when used in areas with high HIV prevalence. South Africa ranks first among all countries for the greatest number of people living with HIV. Notably, South Africa currently offers the J&J-Janssen vaccine—which also uses an adenovirus vector, albeit a different type (Ad26)—as well as the Pfizer-BioNTech and Chinese-made Sinovac vaccines. The Sputnik V vaccine is used in at least 50 countries worldwide but has not yet received emergency use listing status from the WHO.
EFFICACY OF INTERFERON The immunomodulator interferon beta-1a used together with the antiviral remdesivir was no better at treating hospitalized adults with COVID-19 pneumonia than remdesivir alone, according to the results of a study supported by the US NIH. Researchers assigned 969 patients recruited in 63 hospitals across 5 countries 1:1 to receive the study treatment plus remdesivir or a placebo plus remdesivir. According to the results, published online in The Lancet Respiratory Medicine, interferon plus remdesivir was not superior to remdesivir alone, and patients who were on high-flow oxygen at the beginning of the study and took interferon had worse outcomes compared with those who took only the antiviral, possibly due to interferon increasing their inflammatory response.
ABBOTT TEST RECALL Abbott Molecular is recalling 2 of its SARS-CoV-2 laboratory test kits because they have the potential to issue false-positive results, and the US FDA classified it as a Class I recall—the most serious type of recall. The issue is related to the software used with the Alinity m SARS-CoV-2 AMP Kits and Alinity m Resp-4-Plex AMP Kits, and until the software can be updated, positive results should be treated as presumptive, according to the regulatory agency. The FDA previously warned clinical lab staff and healthcare providers of the potential for false positives and urged users to promptly report any adverse events associated with the tests.
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